ONS Putting Evidence into Practice Evidence Table: Lymphedema Literature updated through January 2011

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1 Page 1 of 60 Complete decongestive therapy: RECOMMENDED FOR PRACTICE Karadibak et al, 2008 Primary Aim: to evaluate the effects of kinesiophobia, quality of life, and home exercise programs on women with upper extremity lymphedema Study Procedures All patients underwent complete decongestive physiotherapy consisting of a combination of manual lymph drainages per Foldi s techniques, multi-layer bandages, remedial exercise and skin care Sample Size: 62 patients Age Information / s Gender Females 100% Males 0 Diagnosis Information patients with upper extremity edema following axillary node dissection after sentinel node biopsy as part of breast cancer therapy Other Key Characteristics entry criteria included mild, moderate, severe edema. Patients were excluded if attendance was irregular Single site, outpatient setting Location: Dokuz Eylul University Hospital Circumference measurements using fiberglass tape measure Volumetric measurement using water displacement in water cylinder Fear of movement using TSK scale-ranking based on Likert scale QOL measurement based on FACT-B + 4 questionnaires Results: Edema of armvolume significantly reduced after treatment with decongestive therapy.p=0.000; fear of activity-subject fear of activity decreased after treatment p<0.05: More exercise habits equaled less fear of activity (p=<0.05) Conclusions: correlation between severity of edema and fear of activity established. Increased fear of activity leads to decreased QOL Limitations : Small sample <100 Patients with poor attendance were eliminated from the study analysis Nursing Implications Encouraging activity for the patients post sentinel node biopsy with lymphedema and education is important in the management of patients with lymphedema

2 Didem et al, 2007 Experimental group: CDT therapy that included lymph drainage (Foldi method), multi layer compression bandage, elevation, remedial exercises, and skin care. Control Group: Standard PT that included compression bandages, elevation, head-neck and shoulder exercises, and skin care. Both groups had home pro-gram: bandaging, skin care, and walking. Therapy was three times per week for fourweeks. Study Design: prospective trial N=53 patients with lymphedema post-breast cancer treatment. Randomly assigned and blinded to the intervention. Average duration of lymphedema at the time of treatment was three s. Experimental group: 27 Control Group: 26 Setting: School of Physical Therapy Sample: Mild-to-moderate-degree lymphedema (2 cm circumference difference indicated mild lymphedema; a difference of 2-5 cm shows moderate lymphedema). Lymphedema duration longer than one. Those measuring between two to five cm were excluded from the study if there was obvious psychiatric illness; severe pain in axillary region; severe cardiac disease; uncontrolled hypertension; malignancy Average mean volume: 580 ml Range of motion, circumference measurement, and volumetric measurement were assessed before and after treatment. Circumference measurements: standard one inch, retractable, fiberglass tape measure. Measurements were taken from 10, 15, and 20 cm above and below the olecranon process, at wrist, and at metacorpophalangial joints. Measurements always were taken twice. The same procedure was used for the unaffected arm of each participant. Volumetric: Arm was placed in water-filled container and displaced water was measured. Shoulder mobility: used goniometry. Function was measured as the active mobility with extensionflexion, abduction-adduction, and external rotation Data collected from 53: Mean percentage reduction in edema was 55.7% in CDP group and 36% in SP group (p <0.05). Shoulder mobility: Only 45% had limitation of ROM to start. Reduction in shoulder mobility was 48.1% in CDP group and 42.3% in SP group before treatment. Shoulder flexion, abduction movements in both groups were increased after treatment (p<0.05). No significant difference was found in shoulder external rotation in both groups (p>0.05). No difference between groups in shoulder mobility. Findings with regard to measurements: similar classification of patients using circumferential and volumetric. Therefore, either of the methods can be used. Patients had extensive disease of > 3 s duration. No description of the tissue: pitting fibrotic. Lymphedema was not staged. Small sample size. Thirty-two patients had moderate, 21 had mild. Patients were assessed for type of breast cancer procedures, but this was not used for characterizing the sample. Page 2 of 60

3 Hamner & Fleming, 2007 A retrospective study: The data analysis included medical records of 119 patients with lymphedema secondary to breast cancer who were receiving a CDT protocol of complete decongestive therapy (CDT), Standard protocol of CDT, including MLD; compression bandages; skin care; and exercise. MLD was performed twice weekly by a physical or occupational therapist trained in the Foldi method of lymphatic decongestion. Between sessions, patients wore elastic compression bandages, changed twice daily. Patients were instructed In skin and nail care. Nine had a history of cellulitis, and 44 had no infection; 24.4% had lumpectomies, 64.2% had modified radical mastectomies, and 11.3% had radical mastectomies. Radiotherapy and hormonal therapy: 13.2%; chemotherapy and 49.1% had hormonal therapy. All patients had axillary dissection with a range of 2-35 nodes removed (mean=24.2). Using medical records, data were collected for all patients receiving CDT for lymphedema. Only those with unilateral lymphedema of the upper extremity that resulted from the treatment of breast cancer were included. Therapy included: 1. MLD 2. Compression garments 3. Skin care 4. Range of-motion exercises Therapy was divided into two phases: Induction phase twice weekly for eight weeks and maintenance therapy was individualized to patient needs. Absolute volume and percentage of volume of lymphedema was compared before and after treatment. Pain scale was a 1-to-10 scale. Volumetric measurement: water displacement Mean initial arm volume was 709 ml, and the percentage of lymph was 31%. Induction phase reduced this to 473 ml and 18%. Before therapy, 76 patients had chronic pain, and 41 required oral pain medications. CDT reduced this to 20 and 11 respectively. Pain reduced from 6.9 to 1.1 Exclusion criteria not defined Can t clearly attribute the results to MLD versus physical therapy. Not randomized The degree of chronic pain and the need for pain medication also were assessed. Jeffs, 2005 Page 3 of 60 Treating breast-cancer-related lymphedema at London Haven: 268 eligible patients 1. Severity of swelling at first presentation measured by Results : Mild/Uncomplicated The audit reinforced the need for programs to offer full-service

4 Clinical audit results Clinical audit of effective and ineffective treatment programs Inform the decision-making process regarding focus of care and funding efforts Survey of three s of treatment data Data collected on: Onset and duration of swelling Severity (size and extent) Lymphedema treatment received Changes in severity over time. Patients excluded: patients with advanced disease, those with bilateral lymphedema Ninety-five patients declined treatment at London Haven. N=168 Seventy-four (44%) had f/u data for 12 months for analysis. pero-meter excess limb volume (% excess limb volume or ELV) Mild swelling <20% ELV Moderate 20%-40% ELV Severe >40% ELV 2. Breast /trunk swelling clinically determined by observation/palpation and patient report Treatment 2486 sessions 65% (1608) MLD Optimal intensive treatment program offered to all with moderate to severe LE Only 19 patients were willing to commit to program. Tthis was followed by MLD, compression garments. All patients with moderate to severe LE were taught daily skin care, exercise, and MLD, and compression garments Mild, uncomplicated LE treatment included exercise, skin care, and hosiery. 39/52 (75%) patients with mild/uncomplicated LE received standard self-care regimen of hosiery, exercise, and skin care MEAN reduction of 30% ELV was achieved by 13 patients for whom 12- month data were available 13 (25%) received a short course of MLD (six sessions over two weeks). MEAN reduction was 20% ELV, which is less than that achieved by self-care measures alone* *Some patients in this group had stopped wearing their hosiery because at three and six months they had such improvement. Breast/trunk edema Thirty-nine patients presented with this symptom were treated with MLD, also taught self-massage to14/20 patients for whom 12-month data were available had complete resolution of edema. Moderate-to-severe LE Intensive therapy offered to 77 patients; only 19 (25%) underwent one or more courses of intensive therapy; there was 12-month data on only 16 patients In this high-risk group. At 12 months, swelling had reduced by 40%, and six patients had little of no remaining edema intensive therapy for patients with moderate to severe LE. Breast edema treatment showed most improvement with MLD, self-care For patients unable or unwilling to commit to multilayer bandaging, MLD and self-care, hosiery provided 25% reduction in ELV and warrants further investigation Early treatment advocated as almost 60% of patients developed symptoms within the first postsurgery; only half had sought assist from LE specialist within three months of onset of symptoms. Cohort, observational data Reflects experience of one institution Costs of intensive therapy in terms of time, finances, and access not fully addressed For those patients unable to do intensive therapy, short-course MLD, in addition to self-care hosiery, mean reduction was 25% Koul, et al, 2007 Page 4 of 60 Analyzed: the medical records for 250 patients referred Winnipeg Circumferential measurements from the wrist CDT and MLD with exercises were associated with a significant Nonrandom, no control group One of the inherent problems with

5 for lymphedema treatment during the first two s of the program. Data from the charts of 138 patients were included: their affected arms were larger than their unaffected arms at baseline; one-, follow-up measurements were available. Pre- and post-volumetric measurements were compared, and the correlation with age, BMI, and type of surgery, chemotherapy, and radiotherapy was determined. Treatment was stratified on the basis of the treatment modality used for breast cancer management. The therapy could include all four components of CDT or some components were omitted at the discretion of the therapists. Data from 250 patients was reviewed; 138 were included in the final analysis. Mean age 54.3 s Outpatient lymphedema clinic staffed by two certified Vodder therapists. to axilla q 4 cm. reduction in lymphedema volume. The mean affected arm pretreatment volume was 2929 ml (range ) The normal arm range volume was ( ) with mean volume 2531 ml. The mean difference at base line was 398 ml. The number of MLD or CDT sessions was related to mastectomy (versus lumpectomy) and chemotherapy. Post-treatment: post one : Absolute volume reduction of 188 ml to 2741 ml. researching lymphedema therapy is that typically research must rely on retrospective studies. The value of this study is that it examines the CDT and its Components for a variety of patient needs. Could not qualify the components. Beneficial In that it supports modifications of components of CDT and individualization of care. Evidence supports need for expert therapists. 55% received all four components. 32% received MLD alone. 13% with mild lymphedema received instructions and counseling for the home program, which included self-administered lymph drainage and exercises. All patients received compression wraps during the intensive phase. Compression garments and bandages: RECOMMENDED FOR PRACTICE Damstra, Brouwer & Partsch, 2008 Page 5 of 60 Primary Aim: To demonstrate that therapeutically intended volume reduction of the Sample Size: N=29 (n=20, patients for study group; n=9, healthy volunteers for control group) : Sub-bandage pressure measured by an airfilled pressure Results: A significant reduction of leg volume is achieved 2 hours after Limitations 1: Small sample <30 Single site

6 Damstra & Partsch, 2009 compressed leg is the most important cause for the loss of bandage pressure. Study Procedures: All patients and control group volunteers were treated with the same bandages by trained staff. The bandages started at the base of the toes and covered the leg up to the capitulum fibulae in all cases. The bandages were removed after 2 hours, and new bandages were applied for the next 24 hours. On this first day all patients were encouraged to walk and treated exclusively with compression therapy of the whole leg. No other therapeutic interventions were performed. Primary Aim: To determine whether there is a difference between low and Age Information: mean (range): study group only: 51.1 (20-78); control group: not available Gender (study group only; control group: NA) Females 15 Males 5 Diagnosis Information: Study group consisted of hospitalized patients due to extensive lymphedema of the lower extremities Other Key Characteristics: Setting Type1: Single site Location: Inpatient unit in the Netherlands Study Design: Experimental, controlled comparative study Sample Size: n=36 Age Information: transducer. Water displacement device used to measure leg volumetry. : Bilateral arm volume measurements by bandage application in both groups. A further volume decrease of the lymphedematous legs is observed in the following 24 hours after application of a new bandage. The volume reduction is associated with a significant loss of bandage pressure. Conclusions: Volume reduction is the most important cause of loss of pressure/effectiveness supporting the need for proper materials, technique and compliance. Results: Median arm volume reduction after two and 24 hours was ml (95% Nursing Implications: More frequent bandage changes, in the initial phase of edema reduction in patients with venous diseases, with compression treatment using short-stretch bandages appears to be necessary. Limitations Small sample size <100 Nursing Implications: Page 6 of 60

7 Page 7 of 60 high-pressure bandaging in intended volume reduction Study Procedures: Bilateral arm volume was measured before, 2 hours post bandage placement and after 24 hours. The amount of edema was calculated. Sub-bandage pressure was measured after bandage application and two hours later. Bandages were re-applied and pressure measurements were repeated. After 24 hours, pressure measurement was recorded and bandages were removed for final volumetry. Primary outcome measures were reduction of arm volume/edema in both study groups. Secondary outcomes were changes in sub-bandage pressure and patient comfort laterpatients were randomized into two s Gender: Females 100% Males 0% Diagnosis Information: Unilateral breast cancerrelated lymphedema (moderate to severe edema - volume difference 20%- 40% and > 40% respectively), at least 18 s of age, minimum of 12 months post-treatment for breast cancer without signs of recurrence. Patients were hospitalized because outpatient treatment was not successful. Other Key Characteristics: Patients with allergies to any of the materials, severe systemic diseases, acute superficial or DVT arterial occlusive disease or confirmed thrombophilia were excluded. inverse water volumetry Sub-bandage pressure was measured after bandage application and two hours). The main outcome measures were reduction of arm volume and edema volume in the affected arm in both study groups. Secondary outcome parameters were changes in subbandage pressure and patient comfort.. Air filled pressure transducer with a large probe was used to measure sub-bandage pressure. Accuracy and variability of this method was referenced confidence interval [CI], ) (-2.5%) (P <.0001) and 217 ml (95% CI, ) (-5.2%) (P <.01) for group A and 56.5 ml (95% CI, ) (n.s.) and ml (95% CI, ) (-4.2%) (P <.01) for group B, respectively. There was no statistically significant difference between the volume changes in group A and group B. Bandages in group A were better tolerated. The sub-bandage pressure drop in the first two hours was between 41% and 48% in both treatment groups at both measuring sites. After 24 hours, the pressure drop was between 55% and 63%. No proximal swelling above the bandage was observed. Conclusions: Inelastic, multilayer, multi-component compression bandages with More studies are needed to evaluate efficacy of lower pressure. Important to better understand optimal treatment and tolerability which will impact compliance

8 Kasseroller & Brenner, 2010 Page 8 of 60 groups: group A received low pressure bandages (20-30 mm Hg) and group B received high pressure bandages (44-58 mm Hg Primary Aim: to determine whether a difference exists between conventional and alginate bandaging in the sense of a lower volume increase or re-filling of the lymphoedema, when the bandages are applied in periods with reduced decongestive therapy. Study Procedures: Two groups: A and B. 22 days of treatment with manual lymphatic drainage (MLD) including three inpatient weekends. On inpatient weekends, comparison of two bandages: low-stretch compression dressing and alginate semi-rigid Inpatient single site. Location: Nij Smellinghe hospital in Drachten, Netherlands. Study Design: randomized, controlled comparative study Sample Size: 61 Age Information: The average age of the patients was 57.4 s ±8.926, with a maximum of 81 and a minimum of 28 s. Gender Females 100% Diagnosis Information breast cancer Other Key Characteristics 5 patients had a modified mastectomy;56 lumpectomy;35 patients underwent radiation therapy with 3 of those receiving adjuvant therapy. 41 patients underwent non- : Volume measurement by Kuhnke-starting at ulnar styloid process to proximal circumference was measured every 4 cm Sonograph of skin thickness at middle ventral upper arm, middle ventral forearm, and the middle back of the hand lower pressure (20-30 mm Hg) were better tolerated and achieved the same amount of arm volume reduction as bandages applied with higher pressure (44-58mm Hg) in the first 24 hours Results: there was a statistical difference between the two groups in terms of volume depletion (day 1-5)(p=0.010). (days 5-8)significantly smaller (p=0.001). (days 8-12) insignificant. (days 12-15) significant(p=0.001), (days 15-19) not significant, (days 19-22) significant (p=0.003). All significance in favor of Group B although the overall statistics were not significant. In terms of tolerance, Group B using the alginate semi-rigid bandage had a statistically significant difference in comfort on the second and third weekends. Weekend 2 p value( ) and weekend 3 Limitations 1: Small sample <100 Limitations 2: Nursing Implications: Some positive changes in women with lympedema rely solely on patient education and compliance with exercise. Patient education and physical therapy must be included in post op teaching.

9 Sawan et al, 2009 bandaging. Patients using low-stretch compression dressings (group A) had bandages applied Friday evening after MLD and were instructed to not remove bandaging during sleep and then again on Saturday and Sunday after receiving intermittent pneumatic compression (IPC). Second group (group B) using alginate semi-rigid bandages also were bandaged after MLD on Friday. Patients were instructed to not remove this bandage for the entire weekend. IPC took place in this group with the bandage remaining in place. Volumes were measured prior to bandaging on Friday and then again on Monday prior to MLD. Primary Aim: Feasibility of conducting a larger trial to investigate effectiveness standardized treatment with MLD and a compression garment 6 months prior to admission on study Setting Type1: Single site Setting Type2: Inpatient setting Location: inpatient setting in hospital in Austria Study Design: randomized controlled trial Sample Size: n=14 Age Information: Median Lower limb volume was calculated just above the ankle to at least 4cm p value (0.024). Conclusions: Although there was no significant difference in volume depletion for women from group A vs. Group B, there was a statistically significant difference in the overall comfort of patients in Group B with the semi-rigid bandaging which can directly impact the women s quality of life during treatment for lympedema Results: 11 of 14 patients complied with the entire visit schedule. 2 patients in the Limitations : Small sample <30 Potential bias in this as an Page 9 of 60

10 Page 10 of 60 with use of compression stockings to prevent leg lymphedema after vulval cancer Study Procedures:. 14 patients undergoing inguinofemoral lymphadenectomy were randomized to either the best supportive care (control group) or best supportive care plus the use of graduated compression stockings for 6 months. Patients were seen preoperatively, and followed at 4 weeks, 3 months and 6 months post op. Patients were asked to wear treatment stockings during the daytime for 6 months once mobile beginning no later than 3 days post op. Expected compliance with stockings was 10 hours/day for 180 days. age was 71.5 with a range of Gender: Females 100% Males Diagnosis Information: Vulvar cancer Other Key Characteristics: 14 Women undergoing inguinofemoral lymphadenectomy. Mean BMI 29.4 with range from Setting Type1: Single site Setting Type2: Other inpatient and outpatient Location: Northern Gynaecological Oncology Centre - tertiary referral center covering north east England Study Design: Randomized controlled feasibility study below the perineum. Circumference of the limb was measured using an ordinary tape measure at 4cm intervals commencing approximately 2cm from the lateral malleolus. Nottingham Health Profile. study group had travel hardship and 1 patient was frail and therefore dropped off. 3 patients in the control group failed to comply. Patients in the control group showed greater increase in mean leg volume while those in the treatment arm showed better performance based on leg symptoms and clinical examination. Conclusions: Prophylactic use of stockings is feasible. unblinded study Nursing Implications: Although a small n, quality of life measurements were equal in both groups. Further studies are needed to evaluate the role of compression garments in prevention of lower extremity lymphedema. Stout, Gergich, Successful management of LE N=196 patients: All were women Bilateral UE strength, ROM, The time to onset of LE averaged 6.9 Perometer is a very costly

11 Pfalzer, McGarvey, Springer, Gerber & Soballe, 2008 Page 11 of 60 relies on early diagnosis. The aim of this study was to demonstrate the effectiveness of a surveillance program that included preoperative limb volume measurement and interval postoperative follow-up to detect and treat subclinical LE. Inconsistent measure-ments have prevented a surveillance model from becoming an accepted standard of care. A prospective breast cancer morbidity trial: 1. Limb volume measured prior to surgery and at three-month intervals after surgery. 2. If an increase > 3% in upper limb volume developed compared with the preoerative volume, a diagnosis of LE was made and a compression garment intervention was prescribed for four weeks. Upon reduction of LE, compression was worn only for strenuous activity, with symptoms of heaviness, or with visible swelling with newly diagnosed, unilateral, early-stage Breast cancer (stage I- III) preoperatively Exclusion criteria: previous history of BC, Bilateral BC, prior severe trauma, or surgery of the affected upper extremity.. Inclusion criteria for the compression interventions was a diagnosis of subclinical LE. Diagnostic criteria for subclinical LE : A volume increase >or equal 3% in the affected UE compared with the patient s preoperative measurement and with consideration of the contralateral limb volume changes. This is set below the criteria currently outlined in the medical literature to facilitate early treatment of LE before a clinically apparent onset. Exclusion from the compression sleeve intervention were swelling because of infection or blood clot (n=5). The compression garment was a lightweight Jobst (BSNmedical) ready-made mm/hg compression sleeve and gauntlet fitted by the PT. Two patients required custom-fitted garments because of arm size. Garments were worn daily and no activity limitations were given; patients were advised to follow up for repeated measure in one month. At follow-up, when limb volume decreased, as indicated by the measurements, women were and volume were assessed at the preoperative visit and reassessed at 1, 3, 6, 9, 12, and 18 months postoperatively. Measurements for both UEs were taken in a standard position with the Perometer. LE volume was calculated by suing 80% of the total limb length, which was measured from the styloid process of the ulna to the tip of the acromion for standardization. Body weight was recorded at each visit to control for weight change. months postoperatively. The mean affected limb volume increase was 83 ml at LE onset (P=0.005) compared with baseline. After the intervention, a statistically significant mean 48 ml volume decrease was realized (P<.001). The mean duration of the intervention was 4.4 weeks. Volume reduction was maintained at an average follow-up of 4.8 months after the intervention. A short trial of compression garments effectively treated subclinical lymphedema Detection and management of LE at this early stage may prevent the condition from progressing to a chronic, disabling stage and may enable a more cost-effectiveconservative intervention The authors speak of a shift from current practice pattern in favor of a surveillance model Throughout the surveillance trial, 43 women ages 34 to 82 s were diagnosed with subclinical LE. An age-matched control group (CG) of women without LE was selected from the trial for comparison. machine that required training for patients to use. This makes this unlikely to be replicated. Nevertheless, the results of the study support the continued search for an easy measurement Not a RCT

12 advised to only wear compression for strenuous activity with symptoms of heaviness or with visible swelling Vignes, Porcher, Arrault & Dupuy, 2007 Page 12 of 60 Prospective cohort of 537 patients with secondary arm lymphedema were recruited in a single lymphology unit and followed for 12 months. Lymphedema volume was recorded prior to and at the end of intensive treatment and at month 6 and month 12 follow-up visits. Multivariate models analyzed the role of three components of CDT: manual lymph drainage, low stretch bandage, and elastic sleeve on lymphedema volume during the one- maintenance (after intensive CDT). Lymphedema treatment was managed with an 11-day hospital stay for the intensive therapy. Second the maintenance phase was carried out by the patient and family at home. At the hospital, patient education on implementing self-management was an important goal. Patients and families were taught the selfbandaging technique throughout the intensive phase. Women were reassessed at their next three-month interval surveillance visit for repeated measures, or sooner, if symptoms were exacerbated. N= 537 Lost two to data collection loss and 24 died during follow up.: 426 and 356 patients at M6 and M12. Final size was 426 Female, those referred to the center dedicated to lymphedema management between January 2001 and December Exclusion criteria: past history of lymph reduction by any method. Lymphedema volume was calculated for each 5 cm segment by truncated cone formula. Lymphedema was defined as the difference between the lymphedematous limb (VL) and the healthy limb (VH) Upper limb volumes were measured by the same operator at each of the four measurements. Included at each f/u visit was a recording of treatments applied: MLD, self-bandages and the number per week, and elastic sleeve. Data: breast cancer stage and treatment (age at cancer diagnosis, mastectomy/lumpectomy, radiotherapy, chemotherapy, and anti-estrogens), complications, patient characteristics, BMI date of onset of lymphedema, and lymphedema volume at inclusion. Mean volume of lymphedema was /- 633 ml prior and 647 +/- 351 post intensive decongestive physiotherapy. During the one- maintenance phase therapy, the mean lymphedema volume increased 84 ml. 52% of patients had increased volume above 10% from their value at end of therapy. Noncompliance to low- stretch bandage and elastic sleeve were risk factors for increased lymphedema after one of maintenance treatment (p= < and p = 0.002). Non-compliance to MLD was not a risk factor (p= 0.91). Multivariable covariance analysis model the use of low-stretch selfbandages allowed a 99 ml additional volume reduction during maintenance therapy, compared to no use of bandages. Use of elastic sleeve allowed a 118 ml additional volume reduction during maintenance therapy, compared to no use of elastic sleeve. Effects of self-bandages and elastic sleeve were independent from each other. P=0.49 or interaction). These Limitations: 1. s not randomized so there is no control and cannot identify confounding factors. 2. Large number lost to 12 M f/u 353 to Assessment of compliance not very accurate and only full compliance was noted. 4. Study did not define maintenance MLD.

13 effects did not depend on the magnitude of lymphedema volume During the maintenance phase, compliance to the use of elastic sleeve and low-stretch bandage should be encouraged to stabilize lymphedema volume. Concluded that bandages and elastic sleeve are significant factors for maintenance: wear sleeve daily and self -bandages worn nightly three times per week. MLD did not have an additional independent effect on post-treatment lymphedema. MANUAL LYMPH DRAINAGE: LIKELY TO BE EFFECTIVE McNeely et al., 2004 Page 13 of 60 Purpose of study: compare the reduction in arm lymphedema volume achieved from MLD in combination with CB (MLD/CB) to that achieved by CB alone. s: All subjects receive four weeks of allocated treatment, which also includes standard education on proper arm and skin care. MLD/CB group received 45 minutes of daily MLD Monday through Friday each week. Both groups receive CB. Study was conducted at the Cross Cancer Center in Edmonton, Canada. Study design: prospective, randomized controlled study. Inclusion criteria for Study: Female Breast cancer diagnosis Previous unilateral surgery with axillary node dissection Medical diagnosis of lymphedema No treatment for lymphedema within six months prior to study Exclusion criteria: Distant metastases or local recurrence Current treatment with Two measurement volumes were used to assess lymphedema volume.; water displacement volumetric and calculated volume determined from measurement of circumference. The primary outcome was the volume of lymphedema in the affected arm. Each person s unaffected arm served as a control. Change score was represented by difference in volumes from the initial measurement to the final measurement at the end of four weeks. Data were analyzed comparing baseline characteristics using independent samples t-tests Total of 45 participants completed the study. Findings: A significant reduction in lymphedema volume was found over a four-week period for both MLD/CB and CB groups. No significant difference was noted between the groups on ml reduction (p=0.812) or percent reduction (p=0.297). Therefore, a reduction in lymphedema volume occurred over the time period irrespective of the treatment group. The findings from the calculated volume determined from circumference measurements were consistent with the water displacement findings. Conclusion: Findings suggest that CB alone should be considered as a primary treatment option in reducing Limitations: Looks at effect of treatment on lymphedema volume over a one-month period with no further follow-up. Upper extremity ROM was not assessed. No assessment of effects of treatment on pain, function, body image, and quality of life. Special training needs: Staff that is knowledgeable in application of compression bandaging is required for the intervention. Therapists certified in manual lymph drainage are required. Costs:

14 chemotherapy or radiotherapy Any sign of infection in affected limb Contraindications to intervention therapy for continuous data and Pearson s X 2 for categorical data. Outcome data was analyzed using the independent samples t-tests to compare changes between groups in outcomes from baseline to post-intervention. The rate of reduction was analyzed using a two-way ANOVA repeated measures. Alpha level was set at p<0.05. lymphedema arm volume. It also suggests that treatment of lymphedema should be implemented as soon as possible after onset of the condition when treatment is likely to be more effective. Training and certification of staff. Cost of compression bandages Didem et al, 2007 Page 14 of 60 Experimental group: CDT therapy that included lymph drainage (Foldi method), multi layer compression bandage, elevation, remedial exercises, and skin care. Control Group: Standard PT that included compression bandages, elevation, head-neck and shoulder exercises, and skin care. Both groups had home pro-gram: bandaging, skin care, and walking. Therapy was three times per week for fourweeks. N=53 patients with lymphedema post-breast cancer treatment. Randomly assigned and blinded to the intervention. Average duration of lymphedema at the time of treatment was three s. Experimental group: 27 Control Group: 26 Setting: School of Physical Therapy Sample: Mild-to-moderate-degree lymphedema (2 cm circumference difference indicated mild lymphedema; a difference of 2-5 cm shows moderate lymphedema). Lymphedema duration longer than one. Those measuring between two to five cm were excluded from the study if there was obvious psychiatric illness; severe pain in axillary region; severe cardiac disease; uncontrolled hypertension; malignancy Range of motion, circumference measurement, and volumetric measurement were assessed before and after treatment. Circumference measurements: standard one inch, retractable, fiberglass tape measure. Measurements were taken from 10, 15, and 20 cm above and below the olecranon process, at wrist, and at metacorpophalangial joints. Measurements always were taken twice. The same procedure was used for the unaffected arm of each participant. Volumetric: Arm was placed in water-filled container and displaced water was measured. Shoulder mobility: used goniometry. Function was measured as the active mobility with extensionflexion, abduction-adduction, Data collected from 53: Mean percentage reduction in edema was 55.7% in CDP group and 36% in SP group (p <0.05). Shoulder mobility: Only 45% had limitation of ROM to start. Reduction in shoulder mobility was 48.1% in CDP group and 42.3% in SP group before treatment. Shoulder flexion, abduction movements in both groups were increased after treatment (p<0.05). No significant difference was found in shoulder external rotation in both groups (p>0.05). No difference between groups in shoulder mobility. Findings with regard to measurements: similar classification of patients using circumferential and volumetric. Therefore, either of the methods can be used. Patients had extensive disease of > 3 s duration. No description of the tissue: pitting fibrotic. Lymphedema was not staged. Small sample size.

15 Average mean volume: 580 ml and external rotation Thirty-two patients had moderate, 21 had mild. Patients were assessed for type of breast cancer procedures, but this was not used for characterizing the sample. Koul, et al, 2007 Page 15 of 60 Analyzed: the medical records for 250 patients referred for lymphedema treatment during the first two s of the program. Data from the charts of 138 patients were included: their affected arms were larger than their unaffected arms at baseline; one-, follow-up measurements were available. Pre- and post-volumetric measurements were compared, and the correlation with age, BMI, and type of surgery, chemotherapy, and radiotherapy was determined. Treatment was stratified on the basis of the treatment modality used for breast cancer management. Nine had a history of cellulitis, and 44 had no infection; 24.4% had lumpectomies, 64.2% had modified radical mastectomies, and 11.3% had radical mastectomies. Radiotherapy and hormonal therapy: 13.2%; chemotherapy and 49.1% had hormonal therapy. All patients had axillary dissection with a range of 2-35 nodes removed (mean=24.2). Winnipeg Data from 250 patients was reviewed; 138 were included in the final analysis. Mean age 54.3 s Outpatient lymphedema clinic staffed by two certified Vodder therapists. Circumferential measurements from the wrist to axilla q 4 cm. CDT and MLD with exercises were associated with a significant reduction in lymphedema volume. The mean affected arm pretreatment volume was 2929 ml (range ) The normal arm range volume was ( ) with mean volume 2531 ml. The mean difference at base line was 398 ml. The number of MLD or CDT sessions was related to mastectomy (versus lumpectomy) and chemotherapy. Post-treatment: post one : Absolute volume reduction of 188 ml to 2741 ml. Nonrandom, no control group One of the inherent problems with researching lymphedema therapy is that typically research must rely on retrospective studies. The value of this study is that it examines the CDT and its Components for a variety of patient needs. Could not qualify the components. Beneficial In that it supports modifications of components of CDT and individualization of care. Evidence supports need for expert therapists.

16 The therapy could include all four components of CDT or some components were omitted at the discretion of the therapists. 55% received all four components. 32% received MLD alone. 13% with mild lymphedema received instructions and counseling for the home program, which included self-administered lymph drainage and exercises. All patients received compression wraps during the intensive phase. WEIGHT MANAGEMENT: LIKELY TO BE EFFECTIVE Shaw et al., 2007 Risk factor: Obesity Aim was to compare the effect of two dietary interventions on arm volume in BCRL. To evaluate whether using dietary interventions could be beneficial in the treament of arm LE in patients who have BCRL N=64 women (51 completed) Stratified by volume and treatment then randomized to assure no one group had a disproportionate number of large limbs. Women were randomized to one of three groups for 24 weeks. Three Groups 1. Weight reduction with decreased calories: cal/day 2. Low-fat diet without change in calories: Reduced dietary fat to 20% of total calories 3. Control group without change from intake Randomized controlled trial with two interventions and one control group. Rather ambitious. A simple weight-controlled study may have more advantages. The volume measurements were performed by LE practitioners who were blinded to the intervention Measured at start and at 24 weeks. Using perometer and circumferential: Circumference measured Q 4 cm and then volume is calculated with cir π=vol. Height and weight Skinfold thickness at four sites. Results showed significant reduction in body weight (P=0.006), BMI (p=0.008), and skin fold thickness 4 sites (p=0.044) in the weight-reduction and low-fat groups but not in the controls. There was a reduction in excessive arm volume over the 24 weeks but no significant difference between groups. There was a significant correlation between weight loss and a reduction in excess am volume irrespective of the dietary group (p<0.002). Weight loss each group: Control:9 (60%) Weight reduction:18 (95%) Low-fat: 13 (76%) Weight reduction appears to be an effective means of assisting in the reduction of arm volume during the treatment of the LE arm. Confounding variable: The use of compression or use of MLB during the treatment. Patients used compression sleeves and bandages during the intervention. Nevertheless the patients were distributed throughout the groups Poor adherence to diets Some patients who were instructed not to lose weight did; 1000 to 1200 calories a day is a bit low for anyone Page 16 of 60

17 A good study that identifies an important risk factor and intervention. General Exercise: LIKELY TO BE EFFECTIVE Cinar et al, 2008 Primary Aim: To evaluate the effects of the early onset rehabilitation program on shoulder mobility, functional capacity, lymphedema, and postoperative complications in patients who had modified radical mastectomy (MRM); Study Procedures: Patients were randomly assigned to either treatment group (TG) or home exercise program groups (HG), which were consisted of 27 and 30 patients, respectively. In TG, specific exercise of shoulder hand and elbow ROM exercises under supervision of a physiotherapist until the drains were out, then participants were followed with a physiotherapy Sample Size: 57 total, 27 in the intervention group and 30 in the comparison group. Age Information: about 50 s old Gender: Females 100% Diagnosis Information: The circumferential measurements were used to determine lymphedema. Setting Type1: Single site Setting Type2: Inpatient setting and outpatient setting Location: Turkey Study Design: Randomized controlled trial : The circumferential measurements were used to assess lymphedema The ROM measurements of the shoulder joint at the operation side were measured by Myrin goniometry while the patients were sitting on a chair Functional questionnaire Results: There were statistically significant timerelated changes in all ROM and functional questionnaire scores in both groups. The differences over time in flexion, abduction, and adduction movements were significantly better in TG compared with HG (P <.01, P <.001, P <.005, respectively). The mean range of flexion and abduction returned to almost preoperative values more quickly in TG compared with HG. The recovery of upper extremity functional questionnaire score was also significantly better in TG compared with HG (P <.05). There was no statistically significant difference in circumferential difference between the groups. Limitations Small sample <100 Shorter (only 6 months) follow-up time for the later effect of breast cancer treatment--lymphedema. Nursing Implications: Nurses and clinicians should keep in mind to consult patients with breast cancer to rehabilitation specialist. During the postoperative period, the patients should be followed-up closely to increase their adaptation and compliance to early onset exercise program. Page 17 of 60

18 Hayes, Reul- Hirche & Turner, 2009 program for 8 weeks. In HG, patients received a form to perform the exercises by themselves after removal of the drains. Each exercise was taught by a physiotherapist until the exercise was performed properly. Both groups were informed about skin care and issues that they should take care during daily living activities. Each patient was assessed preoperatively and then postoperatively at fifth day and first, third, and sixth months by another physiotherapist who was blinded to the groups of the patients. Primary Aim: To investigate the effect of participating in a supervised, mixed-type exercise program on lymphedema status among women with lymphedema after breast cancer. Sample Size: 32 Age Information: Mean 59 ages Gender Females 100% Males 0% Lymphedema was assessed via bioimpedance spectroscopy (BIS; SEAC SFB3; Impedimed, Brisbane, Australia) and perometry (Manual Conclusions: Early rehabilitation started on the first postoperative day did not have an adverse effect on local infection, hematoma, and seroma formation and did not cause an increase in duration and amount of lymphatic drainage. Results: There were no significant differences in lymphedema status at baseline or changes between testing phases observed between the intervention and the control groups. Conclusions: Women with Limitations Small sample <100 Only 32 eligible women participated in the study, other 106 women were unable to participate due to the intervention requirements. Page 18 of 60

19 Jonsson & Johansson, 2009 Page 19 of 60 Study Procedures All measures were assessed preintervention (time 1; T1), immediately postintervention (time 2; T2), and at 12-wk follow-up (time 3; T3) and were conducted by the same assessor who was blinded to participant group allocation. Participants were randomly allocated to the intervention group (IG) or the control group (CG) after T1. The intervention involved a 12-wk, mixedtype exercise program, including aerobic and resistance exercise. Primary Aim: To investigate the influence of pole walking on arm lymphedema following breast cancer treatment when using a compression sleeve Study Procedures: Pole Diagnosis Information Diagnosed with breast cancer and objectively measured by perometer with >200ml differences Other Key Characteristics Other 106 women who provided patient and treatment information but were unable to participate due to the intervention requirements. Single site, outpatient setting Location: Queensland Study Design: a randomized controlled trial Sample Size: 26 Age Information age of less than 70 s Gender Females 100% Diagnosis Information Perometer Type 350 S; Pero-System Messgeraete GMBH, Wuppertal, Germany). Qualitative comments regarding the program and the lymphedema status provided by the women during exercise sessions were recorded. : Arm volume: Both arms were measured with the water displacement method and the contralateral arm was used as a control on each occasion. and lymphedema can safely participate in this type of education Results: The patients showed no significant difference in total arm volume (TAV) in the edema arm immediately after pole walking or 24 hours later compared to before walking. Immediately after pole walking, a significant Generalizability for all the women treated for breast cancer should be cautioned. Short term follow up only. Nursing Implications Nurses should be aware that, at minimum, exercise does not exacerbate secondary lymphedema. Women with secondary lymphedema should be encouraged to be physically active, optimizing their physical and psychosocial recovery. Limitations Small sample <30 Out of 42 candidates, only 26 participated in the study. Participation bias should be advised. Nursing Implications

20 walking is a walking exercise with the addition of walking poles that simulates the arm motion of crosscountry skiing during walking. Subjects participated in pole walking on one occasion for 1 hour outdoors in a park and on sidewalks, approximately 4 kilometers for 1 hour. Each session was performed similarly and was supervised by the same person.. Measurements were made before, immediately after, and 24 hours later Kilgour, Jones Primary Aim: A Pilot study & Keyserlink, to the effects of a selfadministered 2008 home-based Page 20 of 60 Arm lymphedema was defined as the affected arm being 5% larger than the contralateral arm also including palpable thickness somewhere in the affected arm compared to the contralateral arm, and/or the patient s experience of tightness in the affected arm. The edema had to be persistent for at least 6 months. Single site Location: Sweden Study Design: Pre-post design Sample Size: 27 registered in milliliters. Total arm volume (TAV) was given in milliliters for both arms. Lymphedema absolute volume (LAV) was calculated as the volume difference between the arms. The lymphedema relative volume (LRV) was calculated in percentage. Subjective lymphedema assessments of experience of heaviness and tightness in the affected while standing with their arms hanging and no arm sleeve on. A 100-millimeter visual analogue scale (VAS) with the endpoints no discomfort (0 mm) and worst imaginable. : Oxford manual muscle testing scale (Standard decrease in lymphedema absolute volume (LAV) and in lymphedema relative volume (LRV) was found, compared to before pole walking. Twenty-four hours later no differences were found compared to before walking. There were no significant differences in rating of heaviness and tightness on the VAS immediately after pole walking or after 24 hours compared to rating before pole walking Conclusions:. A controlled, short-duration pole-walking program can be performed by patients with arm lymphedema, using a compression sleeve, without deterioration of the arm lymphedema. Results: The experimental group demonstrated a significantly greater increase Nurses and clinicians should be aware and encourage women with lymphedema to perform exercises, such as pole walking which seems not to deteriorate the arm lymphedema. Limitations Small sample <30 This is a short study, with

21 exercise (HBE) video program designed to help women regain shoulder mobility immediately following surgery for modified radical mastectomy and axillary node dissection. Study Procedures: Patients were randomly assigned to usual care control or home base exercise groups. Usual care consisted of standard written information on diet and skin care, and a 9 page brochure entitled Exercise Guide after Breast Surgery (printed by CCS, revised October 1997). Participants were not encouraged to follow exercises, nor were they instructed not to do the exercises. The study was conducted during the immediate 2-week recovery period following surgery. Over the next 11 days, Page 21 of 60 Age Information: 49.1 for controls,and 50.6 for exercise group Gender: Females 27 Males 0 Diagnosis Information: All 27 participants had a modified radical mastectomy with axillary node dissection. Other Key Characteristics: exclusions included patients with history or presence of shoulder dysfunction, Older than 65 s, Sentinel Node biopsy dissection only Single site; Outpatient setting Location: Montreal, Canada Study Design: Randomized controlled trial shoulder manual muscle testing techniques) Hand-grip dynamometry Circumferential tape measurements of both extremities Participant self-report Diary Borg;s Category scale for Ratings of Perceived Pain (CR-10 Pain Scale) Borg s Category Scale for Rate of Perceived exertion in flexion ( p =.003) and abduction (p =.036) of shoulder; there was no significant difference in forearm circumference measurements, external rotation, grip strength, or pain. None of the HBE participants demonstrated any significant change in forearm circumference that would indicate lymphedema. Fifty percent of the home exercise group did not complete exercises due to pain at the shoulder joint and axillary swelling, (25%) lack of support from family and others ( 12.5%), and no specific reason (12.5%) Conclusions: Self directed home exercise was associated with greater improvement in some range of motion over time and did not appear to aggravate lymphedema development. There was generally low insufficient evidence about how this program may affect women at longer intervals. The Control group may have completed more exercise than the norm, as were aware of the exercise arm of study, and there was not a control to not exercise. 50% of those in the experimental group did not adhere to the exercise program for a variety of reasons. It is not clear if the exercise program contributed to joint pain and axillary swelling experienced by ¼ of participants. Nursing Implications: This is probably not a strong study to evaluate exercise and the incidence of lymphedema, due to the small sample size, length of study, and measurements method